HPLC法测定盐酸酚苄明有关物质及其片剂的含量  

HPLC determination of hydrochloride phenoxybenzamine tablets and its related substance

作　　者：施青红 李成平[2] 李立[2] 单伟光[3] 

机构地区：[1]浙江工商大学食品生物与环境工程学院,杭州310035 [2]浙江树人大学生物与环境学院,杭州310015 [3]浙江工业大学药学院,杭州310032

出　　处：《药物分析杂志》2008年第6期952-954,共3页Chinese Journal of Pharmaceutical Analysis

基　　金：浙江工业大学省制药重中之重学科开放基金(No.20050602)

摘　　要：目的:建立高效液相色谱法测定盐酸酚苄明片剂的含量。方法:选用 Agilent Eclipse XDB-C_(18)柱(4.6 mm×250 mm,5μm);Lab Alliance C_(18)保护柱(4.6 mm×10 mm,5 μm);流动相:甲醇-水(80:20);流速:1.0 mL·min^(-1);检测波长:272 nm;进量样:20 μL;柱温:25 ℃。结果:方法的线性范围为1.0～200 μg·mL^(-1)(r=0.9999);最低检洲限1.0 ng。回收率在99.7%～101.0%之间,RSD(n=5)在0.68%～2.2%之间。结论:方法简便灵敏,结果准确可靠,可用于酚苄明片剂的质量控制。Objective ：To establish HPLC method for the determination of hydrochloride phenoxybenzamine tablets. Method ：Agilent Eclipse XDB -C18 column （4. 6 mm × 250 mm,5μm）, with the mobile phase consisted of methanol -water（80： 20）, the flow rate was 1.0 mL·min^-1 ,detection wavelength at 272 nm ,the injection volume was 20 μL and external standard method. Results ： The linear range of the method was 1.0 - 200 μg ·mL^-1 （ r = 0. 9999）, the limit of detection was 1.0 ng, the average recovery of artemether was 99. 7% - 101.0%, with RSD of 0.68% - 2.2% （ n = 5 ）. Conclusion ： The method is simple, sensitive, accurate and can be used for the determination hydrochloride phenoxybenzamine tablets.

关 键 词：高效液相色谱法 盐酸酚苄明片 有关物质 

分 类 号：R917[医药卫生—药物分析学]